Skill UI

Provides FDA regulatory consulting for medical device makers, covering pathway choice (510(k)/PMA/De Novo), QSR compliance, HIPAA readiness, and device cybersecurity guidance when preparing submissions or responding to agency inquiries.

Automates compliance and security audit reporting for standards such as PCI DSS, HIPAA, SOC 2, and ISO 27001 by using the compliance-report-generator plugin to collect details, format documentation, and streamline regulatory proof.

Guides HealthTech and MedTech teams through FDA 510(k)/De Novo/PMA and EU MDR CE marking, drafting strategy documents, agency responses, and multi-market plans for device submissions and compliance.

Provides hands-on compliance expertise for GDPR, HIPAA, SOC2, PCI-DSS and other industry standards, guiding audits, control implementation, monitoring, and reporting to keep software systems aligned with regulatory expectations.

Codified procedures for customs and trade compliance, covering HS tariff classification, documentation, Incoterms, duties, and regulatory controls when importing or exporting goods across jurisdictions.

Generate publication-ready clinical decision support documents for pharmaceutical and research teams, including biomarker-stratified cohort analyses and evidence-graded treatment recommendation reports with statistical and regulatory compliance details.

Suite of 12 production-ready HealthTech/MedTech regulatory and quality management skills covering ISO 13485, MDR 2017/745, FDA 510(k)/PMA, ISO 27001, GDPR/DSGVO, risk management, CAPA, documentation, and audits, plus stdlib Python helpers for compliance workflows.